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NCT Number: NCT07091539

Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study

This proposal addresses a critical gap in the understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. Evidence from adult studies links household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly fourfold increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient-poor foods (e.g., sugar-sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to assess whether a clinic-based fruit/vegetable voucher intervention program (EatSF) could potentially improve clinical outcomes for children/adolescents with MASLD and household FI. Study participants include children/adolescents with household FI and MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic. The study seeks to identify barriers and facilitators to fruit/vegetable voucher redemption, and assess changes in dietary intake, MASLD severity, and other cardiometabolic health factors in children participating in the pilot intervention. Study findings will form the basis of an R01 application to conduct a fully powered randomized controlled trial of the intervention.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

About this study

Study designs for each of the three specific aims are below:

Aim 1: Assess participation in the EatSF intervention (to be piloted in the liver and WATCH clinics) among families with a child with MASLD and household FI, as identified through an observational cross-sectional study.

Design: To achieve this aim, the investigators will conduct a 6-month pre-post one-arm pilot intervention study of the EatSF Vouchers4Veggies fruit and voucher program with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics. At the end of the 6-month intervention period, the investigators will assess the percentage of vouchers redeemed through a software program developed by EatSF Vouchers4Veggies. Also at the end of the 6-month intervention, the CRC will administer study assessments comparable to those conducted at baseline as part of the observational cross-sectional study (for which IRB approval has been submitted). Also at the end of the 6-month intervention, the CRC will conduct semi-structured interviews to identify barriers and facilitators to:

  • voucher redemption,
  • adhering to clinic dietary recommendations, and
  • parental understanding of MASLD and the role of diet in its management.

Aim 2: Assess changes in dietary intake in children with MASLD and FI participating in the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at the UCSF liver or WATCH Clinics (projected n=48).

Design: To achieve this aim, the investigators will analyze changes in the baseline data collected as part of the observational cross-sectional study (for which IRB approval has been submitted) with post-test data (collected at the end of the six-month pilot study).

Exploratory Aim 3: Assess changes in liver inflammation measured by alanine aminotransferase serum lab (ALT) (GGT), and other cardiometabolic health factors in children with MASLD and household FI from baseline to the end of the 6-month study.

Design: To achieve this aim, the investigators will analyze data collected from the 6-month pre-post one-arm pilot intervention study with families with a child with household FI and MASLD who receive care at UCSF's liver and WATCH clinics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics.

Inclusion criteria

include:

  • family living in California;
  • a parent/guardian who speaks Spanish or English,
  • child is between the ages of 6 to <18 years;
  • child has elevated BMI greater than or equal to 85% for age and sex
  • child has ALT value greater than 26 for boys and 22 for girls on two occasions within the last year; OR one elevated ALT value and imaging confirming steatosis
  • family does not intend to move out of California for the next year;
  • family is not already receiving EatSF Fruit and Vegetable Vouchers;
  • family is not participating in any other dietary education programs besides that offered by the liver/ WATCH clinics

Exclusion criteria

  • child has an underlying condition or medication causing their weight gain (i.e., hypothyroidism, Prader-Willi syndrome, antipsychotic medications) or a known liver condition other than MASLD/MASH causing their elevated liver numbers;
  • child is on a weight loss medication (including: Qsymia or GLP-1 receptor agonists),
  • both of which are assessed as part of routine clinical care.

Treatment and study plan

Fruit/vegetable vouchers

Other

The intervention is $80 of fruit/vegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months

Primary outcomes

  1. Voucher participation

    Time frame: From enrollment to the end of the six month intervention

    What percentage of money of the vouchers were used monthly

  2. Changes in dietary intake

    Time frame: From baseline to the end of the six month intervention

    Assess changes in dietary intake in children with MASLD and FI participating in the 6 month pre-post one arm pilot intervention studies.

  3. changes in liver inflammation and other cardiometabolic health factors

    Time frame: From baseline to the end of the six months study.

    Assess changes in liver inflammation as measured by ALT and GGT and other cardiometabolic health factors in children with MASLD and FI from baseline to the end of the six months study.

Other outcomes

  1. Semi-structured interviews

    Time frame: At the end of the six month intervention

    At the end of the six months, semi-structured interviews will be conducted to identify barriers and facilitators to voucher redemption, adhering to clinic recommendations, and to explore the parental understanding of MASLD and the role of diet in its management.

Study contacts

Contact information is provided by the study sponsor or research team.

Milagro Escobar

CONTACT

[email protected]

4155197863

Sarah L Maxwell, MD

CONTACT

[email protected]

4155197863

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Gastroenterological Association

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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